Renal and Cardiac Risk Factors of AKI After Liver Transplantation

NCT ID: NCT05666232

Last Updated: 2022-12-27

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 105 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-01-31
• Study Completion Date: 2024-04-30

Brief Summary

Background: Liver transplantation (LT) is an extensive operation with various factors contributing to the development of acute kidney injury in the perioperative period. Early diagnosis of AKI can improve clinical outcomes in LT recipients. Renal resistive index is measured in renal arteries and high resistive values are associated with more adverse cardiovascular events and renal failure progression. Myocardial performance index reflects overall cardiac function rather than systolic or diastolic function alone.

Aim of the study: to investigate whether combined doppler renal resistive index and myocardial performance index could predict early postoperative acute kidney injury in living donor liver transplant recipients.

Study design: a prospective observational study that will be conducted at Liver Transplantation Unit at Mansoura University on 105 consecutive living donor liver transplant recipients.

Methods: Renal resistive index (assessed by transabdominal ultrasound) and myocardial performance index (assessed by transthoracic echocardiography) will be measured just before operation, on termination of operation and then daily in the intensive care unit for 7 days. Patients will be observed for development of acute kidney injury.

Detailed Description

This study aims to investigate whether combined doppler renal resistive index (RRI) assessed by transabdominal sonography and myocardial performance index (MPI) assessed by transthoracic echocardiography could predict early postoperative acute kidney injury in living donor liver transplant recipients.

The primary outcome is the predictive value of renal resistive index and myocardial performance index for the onset of early post living donor liver transplant acute kidney injury.

This prospective observational study will be conducted at Liver Transplantation Unit at Mansoura University from November 2022 till fulfillment of sample size after obtaining approval from Institutional Review Board (IRB). One hundred and five consecutive LDLT recipients will participate in this study after obtaining informed consents. They will be observed for the development of early postoperative acute kidney injury.

Conditions

Acute Kidney Injury; Acute Renal Injury; Liver Transplant; Complications

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

renal resistive index and myocardial performance index

Transthoracic echocardiography and transabdominal ultrasonography will be performed before induction of anesthesia, after termination of operation and before transmission to ICU and then daily for the early seven postoperative days.

RRI = (peak systolic velocity - end diastolic velocity) ∕ peak systolic velocity: Then, we will obtain the mean RRI from the above three measurements.

We will consider RRI ≥0.7 as abnormal and define it as subclinical AKI.

Myocardial performance index (using tissue doppler) =

(isovolumetric contraction time + isovolumetric relaxation time) / ejection time. We will consider MPI ≥0.4 as abnormal and define it as subclinical LV dysfunction.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

echocardiography; ultrasonography

Eligibility Criteria

Inclusion Criteria

• patients undergoing right-lobe living-donor liver transplantation

Exclusion Criteria

• preoperative renal impairment (GFR < 60 ml/min/1.73 m2)
• known renal artery stenosis
• patient who underwent previous nephrectomy
• ischemic heart disease (patient who takes anti-ischemic measures as prescribed by a consultant cardiologist)
• Patient with arrthymia or who develop persistent intraoperative arrythmia

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amr Yassen, MD

Role: STUDY_CHAIR

Mansoura University Hospital

Central Contacts

Ahmed Ali El-din, MSc

Role: CONTACT

ahmedalieldin2000@gmail.com

1288045390 ext. +20

Moataz M Emara, MD, EDAIC

Role: CONTACT

mm.emara@mans.edu.eg

1064048848 ext. +20

Other Identifiers

MD.22.09.699

Identifier Type: -

Identifier Source: org_study_id